The treatment landscape in thyroid cancer: A focus on cabozantinib

Cancer Management and Research

Volumn 7, Issue , 2015, Pages 265-278

  Weitzman, Steven P ^a   Cabanillas, Maria E ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Adverse event; Chemotherapy; Kinase inhibitor; RET; Targeted therapy; VEGF

Indexed keywords

ANTHRACYCLINE; APPETITE STIMULANT; BUDESONIDE; CABOZANTINIB; CORTICOSTEROID; LENVATINIB; LOPERAMIDE; MULTIKINASE INHIBITOR; OCTREOTIDE; PHOSPHOTRANSFERASE INHIBITOR; PLATINUM COMPLEX; SORAFENIB; TAXANE DERIVATIVE; THYROTROPIN; UNCLASSIFIED DRUG; VANDETANIB;

ABNORMAL LABORATORY RESULT; ADVANCED CANCER; ANAPLASTIC THYROID CANCER; ARTERY THROMBOSIS; ARTICLE; BLEEDING; BODY WEIGHT DISORDER; BONE NECROSIS; CANCER CHEMOTHERAPY; CANCER EPIDEMIOLOGY; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CARCINOGENESIS; CHEMOEMBOLIZATION; CLINICAL TRIAL (TOPIC); CRYOABLATION; DECREASED APPETITE; DIARRHEA; DIFFERENTIATED THYROID CANCER; DISTANT METASTASIS; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG MONITORING; DRUG SAFETY; DYSGEUSIA; FATIGUE; FISTULA; HAIR DISCOLORATION; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; HYPOCALCEMIA; HYPOMAGNESEMIA; INTESTINE PERFORATION; MOLECULARLY TARGETED THERAPY; NAUSEA; PATIENT DECISION MAKING; PATIENT SELECTION; POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME; PROTEINURIA; RECURRENT DISEASE; RISK BENEFIT ANALYSIS; SALVAGE THERAPY; SKIN MANIFESTATION; STOMATITIS; THYROID CANCER; THYROID MEDULLARY CARCINOMA; THYROIDECTOMY; TREATMENT INDICATION; VEIN THROMBOSIS; VOMITING; WEIGHT REDUCTION; WOUND COMPLICATION;

EID: 84940038624     PISSN: None     EISSN: 11791322     Source Type: Journal    
DOI: 10.2147/CMAR.S68373     Document Type: Article

References (83)

1. COMETRIQ™ [package insert]. South San Francisco, CA: Exelixis, Inc.; 2012. Available from: http://www.cometriq.com/downloads/Cometriq_Full_Prescribing_Information.pdf. Accessed March 29, 2015.
2. National Cancer Institute at the National Institutes of Health. Cancer of the Thyroid – SEER Stat Fact Sheets. Bethesda, MD: National Cancer Institute at the National Institutes of Health. Available from: http://seer.cancer.gov/statfacts/html/thyro.html. Accessed March 27, 2015.
3. Ruegemer JJ, Hay ID, Bergstralh EJ, Ryan JJ, Offord KP, Gorman CA. Distant metastases in differentiated thyroid carcinoma: a multivariate analysis of prognostic variables. J Clin Endocrinol Metab. 1988;67(3): 501–508.
4. Besic N, Gazic B. Sites of metastases of anaplastic thyroid carcinoma: autopsy findings in 45 cases from a single institution. Thyroid. 2013; 23(6):709–713.
5. Aschebrook-Kilfoy B, Ward MH, Sabra MM, Devesa SS. Thyroid cancer incidence patterns in the United States by histologic type, 1992–2006. Thyroid. 2011;21(2):125–134.
6. Krampitz GW, Norton JA. RET gene mutations (genotype and phenotype) of multiple endocrine neoplasia type 2 and familial medullary thyroid carcinoma. Cancer. 2014;120(13):1920–1931.
7. Moura MM, Cavaco BM, Pinto AE, Leite V. High prevalence of RAS mutations in RET-negative sporadic medullary thyroid carcinomas. J Clin Endocrinol Metab. 2011;96(5):E863–E868.
8. Capp C, Wajner SM, Siqueira DR, Brasil BA, Meurer L, Maia AL. Increased expression of vascular endothelial growth factor and its receptors, VEGFR-1 and VEGFR-2, in medullary thyroid carcinoma. Thyroid. 2010;20(8):863–871.
9. The Cancer Genome Atlas Research Network. Integrated genomic characterization of papillary thyroid carcinoma. Cell. 2014;159(3):676–690.
10. Nikiforova MN, Nikiforov YE. Molecular genetics of thyroid cancer: implications for diagnosis, treatment and prognosis. Expert Rev Mol Diagn. 2008;8(1):83–95.
11. Abdel-Rahman O. Targeting vascular endothelial growth factor (VEGF) pathway in iodine-refractory differentiated thyroid carcinoma (DTC): from bench to bedside. Crit Rev Oncol Hematol. 2015;94(1):45–54.
12. de Araujo-Filho VJ, Alves VA, de Castro IV, et al. Vascular endothelial growth factor expression in invasive papillary thyroid carcinoma. Thyroid. 2009;19(11):1233–1237.
13. Ricarte-Filho JC, Ryder M, Chitale DA, et al. Mutational profile of advanced primary and metastatic radioactive iodine-refractory thyroid cancers reveals distinct pathogenetic roles for BRAF, PIK3CA, and AKT 1. Cancer Res. 2009;69(11):4885–4893.
14. Schwartz DL, Rana V, Shaw S, et al. Postoperative radiotherapy for advanced medullary thyroid cancer – local disease control in the modern era. Head Neck. 2008;30(7):883–888.
15. Lindsey SC, Ganly I, Palmer F, Tuttle RM. Response to initial therapy predicts clinical outcomes in medullary thyroid cancer. Thyroid. 2015;25(2):242–249.
16. Wells SA Jr, Asa SL, Dralle H, et al. Revised american thyroid association guidelines for the management of medullary thyroid carcinoma. Thyroid. 2015;25(6):567–610.
17. Yeh MW, Bauer AJ, Bernet VA, et al. American thyroid association statement on preoperative imaging for thyroid cancer surgery. Thyroid. 2015;25(1):3–14.
18. Tuttle RM, Haddad RI, Ball DW, et al. Thyroid carcinoma, version 2. 2014. J Natl Compr Canc Netw. 2014;12(12):1671–1680.
19. Cooper DS, Doherty GM, Haugen BR, et al. Revised american thyroid association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19(11):1167–1214.
20. Brignardello E, Palestini N, Felicetti F, et al. Early surgery and survival of patients with anaplastic thyroid carcinoma: analysis of a case series referred to a single institution between 1999 and 2012. Thyroid. 2014; 24(11):1600–1606.
21. Mohebati A, Dilorenzo M, Palmer F, et al. Anaplastic thyroid carcinoma: a 25-year single-institution experience. Ann Surg Oncol. 2014;21(5):1665–1670.
22. Smallridge RC, Ain KB, Asa SL, et al. American thyroid association guidelines for management of patients with anaplastic thyroid cancer. Thyroid. 2012;22(11):1104–1139.
23. Haymart MR, Banerjee M, Yin H, Worden F, Griggs JJ. Marginal treatment benefit in anaplastic thyroid cancer. Cancer. 2013;119(17):3133–3139.
24. Durante C, Haddy N, Baudin E, et al. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab. 2006;91(8):2892–2899.
25. Orita Y, Sugitani I, Toda K, Manabe J, Fujimoto Y. Zoledronic acid in the treatment of bone metastases from differentiated thyroid carcinoma. Thyroid. 2011;21(1):31–35.
26. Gherardi E, Birchmeier W, Birchmeier C, Vande Woude G. Targeting MET in cancer: rationale and progress. Nat Rev Cancer. 2012;12(2): 89–103.
27. Aftab DT, McDonald DM. MET and VEGF: synergistic targets in castration-resistant prostate cancer. Clin Transl Oncol. 2011;13(10): 703–709.
28. Shojaei F, Lee JH, Simmons BH, et al. HGF/c-Met acts as an alternative angiogenic pathway in sunitinib-resistant tumors. Cancer Res. 2010;70(24):10090–10100.
29. Yakes FM, Chen J, Tan J, et al. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther. 2011;10(12):2298–2308.
30. Tohyama O, Matsui J, Kodama K, et al. Antitumor activity of lenvatinib (e7080): an angiogenesis inhibitor that targets multiple receptor tyrosine kinases in preclinical human thyroid cancer models. J Thyroid Res. 2014;2014:638747.
31. Kumar R, Knick VB, Rudolph SK, et al. Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity. Mol Cancer Ther. 2007;6(7):2012–2021.
32. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004;64(19):7099–7109.
33. Plaza-Menacho I, Mologni L, Sala E, et al. Sorafenib functions to potently suppress RET tyrosine kinase activity by direct enzymatic inhibition and promoting RET lysosomal degradation independent of proteasomal targeting. J Biol Chem. 2007;282(40):29230–29240.
34. Carlomagno F, Anaganti S, Guida T, et al. BAY 43-9006 inhibition of oncogenic RET mutants. J Natl Cancer Inst. 2006;98(5):326–334.
35. Wilhelm S, Carter C, Lynch M, et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat Rev Drug Discov. 2006;5(10):835–844.
36. Faivre S, Demetri G, Sargent W, Raymond E. Molecular basis for sunitinib efficacy and future clinical development. Nat Rev Drug Discov. 2007;6(9):734–745.
37. Kim DW, Jo YS, Jung HS, et al. An orally administered multitarget tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/papillary thyroid cancer kinases. J Clin Endocrinol Metab. 2006;91(10):4070–4076.
38. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther. 2003;2(5):471–478.
39. Wedge SR, Ogilvie DJ, Dukes M, et al. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res. 2002;62(16):4645–4655.
40. Carlomagno F, Vitagliano D, Guida T, et al. ZD6474, an orally available inhibitor of KDR tyrosine kinase activity, efficiently blocks oncogenic RET kinases. Cancer Res. 2002;62(24):7284–7290.
41. Kurzrock R, Sherman SI, Ball DW, et al. Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol. 2011;29(19):2660–2666.
42. Schlumberger M, Elisei R, Muller S, et al. Final overall survival analysis of EXAM, an international, double-blind, randomized, placebo-controlled phase Ill trial of cabozantinib (Cabo) in medullary thyroid carcinoma (MTC) patients with documented RECIST progression at baseline. Presented at: The 2015 Annual Meeting of the American Society of Clinical Oncology, Chicago, IL; 2015. Abstract 6012.
43. Elisei R, Schlumberger MJ, Muller SP, et al. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013;31(29):3639–3646.
44. US Food and Drug Administration. Approved Drugs: Cabozantinib; 2012. Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm330213.htm. Accessed March 29, 2015.
45. US Food and Drug Administration. FDA approves new treatment for rare form of thyroid cancer [Press Announcements]. Silver Spring, MD: US Food and Drug Administration; [April 6, 2011]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250168.htm. Accessed April 29, 2015.
46. Wells SA Jr, Robinson BG, Gagel RF, et al. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012;30(2):134–141.
47. US Food and Drug Administration. FDA approves Nexavar to treat type of thyroid cancer [Press Announcements]. Silver Spring, MD: US Food and Drug Administration; [November 22, 2013]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376443.htm. Accessed April 5, 2015.
48. Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet. 2014;384(9940):319–328.
49. US Food and Drug Administration. FDA approves Lenvima for a type of thyroid cancer [Press Announcements]. Silver Spring, MD: US Food and Drug Administration; [February 13, 2015]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434288.htm. Accessed April 5, 2015.
50. Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372(7): 621–630.
51. Nguyen L, Holland J, Miles D, et al. Pharmacokinetic (PK) drug interaction studies of cabozantinib: effect of CYP3A4 inducer rifampin and inhibitor ketoconazole on cabozantinib plasma PK, and effect of cabozantinib on CYP2C8 probe substrate rosiglitazone plasma PK. J Clin Pharmacol. Epub April 8, 2015.
52. Abramson Cancer Center of the University of Pennsylvania. A phase II trial of cabozantinib for the treatment of radioiodine (RAI)-refractory differentiated thyroid carcinoma (DTC) in the first-line setting. Available from: https://clinicaltrials.gov/show/NCT 02041260. NLM identifier: 02041260. Accessed April 5, 2015.
53. National Cancer Institute. Cabozantinib-s-malate in treating patients with refractory thyroid cancer. Available from: https://clinicaltrials.gov/show/NCT 01811212. NLM identifier: 01811212. Accessed April 5, 2015.
54. Bible KC, Suman VJ, Menefee ME, et al. A multiinstitutional phase 2 trial of pazopanib monotherapy in advanced anaplastic thyroid cancer. J Clin Endocrinol Metab. 2012;97(9):3179–3184.
55. Savvides P, Nagaiah G, Lavertu P, et al. Phase II trial of sorafenib in patients with advanced anaplastic carcinoma of the thyroid. Thyroid. 2013;23(5):600–604.
56. Sosa JA, Elisei R, Jarzab B, et al. Randomized safety and efficacy study of fosbretabulin with paclitaxel/carboplatin against anaplastic thyroid carcinoma. Thyroid. 2014;24(2):232–240.
57. Takahashi S, Tahara M, Kiyota N, et al. Phase II study of lenvatinib, a multitargeted tyrosine kinase inhibitor, in patients with all histologic subtypes of advanced thyroid cancer (differentiated, medullary, and anaplastic). Poster presented at: European Society for Medical Oncology 2014 Congress, September 26–30, 2014, Madrid, Spain. Abstract #995PD. Available from: http://oncologypro.esmo.org/Meeting-Resources/ESMO-2014/Head-and-Neck-Cancer/Phase-II-study-of-lenvatinib-LEN-a-multi-targeted-tyrosine-kinase-inhibitor-in-patients-pts-with-all-histologic-subtypes-of-advanced-thyroid-cancer-differentiated-medullary-and-anaplastic. Accessed July 11, 2015.
58. Eisai Co, Ltd. Eisai receives approval in Japan for anticancer agent Lenvima (lenvatinib mesylate) as treatment for unresectable thyroid cancer;2015. Available from: http://www.eisai.com/news/news201520.html. Accessed April 8, 2015.
59. GlaxoSmithKline. Efficacy and safety of the combination therapy of dabrafenib and trametinib in subjects with BRAF V600E-mutated rare cancers. Available from: https://clinicaltrials.gov/show/NCT 02034110. NLM identifier: NCT 02034110. Accessed April 13, 2015.
60. National Cancer Institute. Intensity-modulated radiation therapy and paclitaxel with or without pazopanib hydrochloride in treating patients with anaplastic thyroid cancer. Available from: https://clinicaltrials.gov/show/NCT 01236547. NLM identifier: NCT 01236547. Accessed March 29, 2015.
61. US National Institutes of Health. Home – ClinicalTrials.gov. Available from: https://clinicaltrials.gov/. Accessed April 12, 2015.
62. Fagin JA, Tuttle RM, Pfister DG. Harvesting the low-hanging fruit: kinase inhibitors for therapy of advanced medullary and nonmedullary thyroid cancer. J Clin Endocrinol Metab. 2010;95(6):2621–2624.
63. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
64. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92(3):205–216.
65. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982; 5(6):649–655.
66. Cabanillas ME, Hu MI, Jimenez C. Medullary thyroid cancer in the era of tyrosine kinase inhibitors: to treat or not to treat – and with which drug – those are the questions. J Clin Endocrinol Metab. 2014;99(12):4390–4396.
67. Blevins DP, Dadu R, Hu M, et al. Aerodigestive fistula formation as a rare side effect of antiangiogenic tyrosine kinase inhibitor therapy for thyroid cancer. Thyroid. 2014;24(5):918–922.
68. Cabanillas ME, Brose MS, Holland J, Ferguson KC, Sherman SI. A phase I study of cabozantinib (XL184) in patients with differentiated thyroid cancer. Thyroid. 2014;24(10):1508–1514.
69. Neri A, Lambert Y, Marrelli D, et al. Gastro-pleuro-pericardial fistula following combined radiation and chemotherapy for lung metastases from renal cell carcinoma: report of a case. Surg Today. 2013;43(12): 1457–1460.
70. Smith MR, Sweeney CJ, Corn PG, et al. Cabozantinib in chemotherapy-pretreated metastatic castration-resistant prostate cancer: results of a phase II nonrandomized expansion study. J Clin Oncol. 2014;32(30): 3391–3399.
71. Marino R, Orlandi F, Arecco F, Gandolfo S, Pentenero M. Osteonecrosis of the jaw in a patient receiving cabozantinib. Aust Dent J. Epub December 4, 2014.
72. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0; 2009. Available from: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference:8.5x11.pdf. Accessed April 23, 2015.
73. Carhill AA, Cabanillas ME, Jimenez C, et al. The noninvestigational use of tyrosine kinase inhibitors in thyroid cancer: establishing a standard for patient safety and monitoring. J Clin Endocrinol Metab. 2013;98(1): 31–42.
74. Exelixis. A study of two different doses of cabozantinib (XL184) in progressive, metastatic medullary thyroid cancer (EXAMINER). Available from: https://clinicaltrials.gov/show/NCT 01896479. NLM Identifier: 01896479. Accessed April 5, 2015.
75. Bible KC, Ain KB, Rosenthal MS. Protein kinase inhibitor therapy in advanced thyroid cancer: ethical challenges and potential solutions. Int J Endocr Oncol. 2014;1(2):145–151.
76. Cabanillas ME, Hu MI, Jimenez C, Grubbs EG, Cote GJ. Treating medullary thyroid cancer in the age of targeted therapy. Int J Endocr Oncol. 2014;1(2):203–216.
77. Yavuz S, Apolo AB, Kummar S, et al. Cabozantinib-induced thyroid dysfunction: a review of two ongoing trials for metastatic bladder cancer and sarcoma. Thyroid. 2014;24(8):1223–1231.
78. Sherman S, Schlumberger M, Tahara M, et al. Relationship between thyroid-stimulating hormone levels and outcomes from the randomized, double-blind, phase 3 study of (E7080) lenvatinib in differentiated cancer of the thyroid (SELECT). Poster presented at: The 97th Annual Meeting of the Endocrine Society, San Diego, CA; 2015. Abstract THR-331.
79. Kwatampora L, Cabanillas M, Korivi B, Fogelman D, Dadu R, Busaidy N. Effect of cabozantinib on body composition in advanced thyroid cancer. Poster presented at: The 97th Annual Meeting of the Endocrine Society, San Diego, CA; 2015. Abstract #THR-050.
80. Fallahi P, Mazzi V, Vita R, et al. New therapies for dedifferentiated papillary thyroid cancer. Int J Mol Sci. 2015;16(3):6153–6182.
81. Weitzman S, Peicher K, Dadu R, et al. Salvage therapy: when a tyrosine kinase inhibitor (TKI) fails in advanced medullary thyroid cancer (MTC). Poster presented at: The 97th Annual Meeting of the Endocrine Society, San Diego, CA; 2015. Abstract OR44-44.
82. Dadu R, Devine C, Hernandez M, et al. Role of salvage targeted therapy in differentiated thyroid cancer patients who failed first-line sorafenib. J Clin Endocrinol Metab. 2014;99(6):2086–2094.
83. Cabanillas ME, Hu MI, Jimenez C. Medullary thyroid cancer in the era of tyrosine kinase inhibitors: to treat or not to treat–and with which drug – those are the questions. J Clin Endocrinol Metab. 2014; 99(12):4394.